Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 1 of 17 PageID #: 4855
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`SANOFI-AVENTIS U.S. LLC, et al.,
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`Plaintiffs,
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`V.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`Civil Action No. 14-113-RGA-MPT
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`MEMORANDUM OPINION
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`Steven J. Balick, Esq., Tiffany Geyer Lydon, Esq., Andrew C. Mayo, Esq., ASHBY &
`GEDDES, Wilmington, DE; Mark A. Perry, Esq., GIBSON, DUNN & CRUTCHER LLP,
`Washington, D.C.; Joseph Evall, Esq. (argued), R. Scott Roe, Esq. (argued), GIBSON, DUNN &
`CRUTCHER LLP, New York, NY; Tracey Davies, Esq. (argued), GIBSON, DUNN &
`CRUTCHER LLP, Dallas, TX; Frederick Brown, Esq., GIBSON, DUNN & CRUTCHER LLP,
`San Francisco, CA; Y. Ernest Hsin, Esq. (argued), GIBSON, DUNN & CRUTCHER LLP, Palo
`Alto, CA.
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`Attorneys for Plaintiffs Sanofi-Aventis U.S. LLC, et al.
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`Brian E. Farnan, Esq., Michael J. Farnan, Esq., FARNAN LLP, Wilmington, DE; Bruce M.
`Wexler, Esq. (argued), Joseph M. O'Malley, Jr., Esq., David M. Conca, Esq. (argued), Young
`Park, Esq., Nicholas A. Tymoczko, Esq., PAUL HASTINGS LLP, New York, NY.
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`Attorneys for Defendant Eli Lilly and Company.
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`January Ju, 2015
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 2 of 17 PageID #: 4856
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`A~~~E:
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`Pending before the Court is the issue of claim construction for the disputed terms found
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`in U.S. Patent Nos. 7,476,652 and 7,713,930 (collectively, the "Formulation Patents") and
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`8,556,864; 8,603,044; and 8,679,069 (collectively, the "Device Patents"). 1
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`I.
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`BACKGROUND
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`Plaintiff Sanofi-Aventis ("Sanofi") filed this action for patent infringement on January
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`30, 2014. The Court has considered the parties' joint claim construction brief(D.I. 137),joint
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`appendix (D.I. 138), and oral argument (D.I. 178).2
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`II.
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`LEGALSTANDARD
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`"It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). '" [T]here is no magic formula or
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`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
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`weight to appropriate sources 'in light of the statutes and policies that inform patent law."'
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`Soft View LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
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`415 F.3d at 1324). When construing patent claims, a matter of law, a court considers the literal
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`language of the claim, the patent specification, and the prosecution history. Markman v.
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`Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370
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`(1996). Of these sources, "the specification is always highly relevant to the claim construction
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`1 Except for the claims, the '044 patent and '069 patent are almost identical. For the sake of simplicity, all citations
`are to the '044 patent, unless specified otherwise.
`2 The parties did not argue all disputed terms. (D.I. 162).
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 3 of 17 PageID #: 4857
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`analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."
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`Phillips, 415 F.3d at 1315 (internal quotation marks and citations omitted).
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`"[T]he words of a claim are generally given their ordinary and customary meaning ....
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`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application."
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`Phillips, 415 F.3d at 1312-13 (internal quotation marks and citations omitted). "[T]he ordinary
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`meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent."
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`Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim
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`language as understood by a person of skill in the art may be readily apparent even to lay judges,
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`and claim construction in such cases involves little more than the application of the widely
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`accepted meaning of commonly understood words." Id. at 1314 (internal citations omitted).
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`A court may consider extrinsic evidence, which "consists of all evidence external to the
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`patent and prosecution history, including expert and inventor testimony, dictionaries, and learned
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`treatises," in order to assist the court in understanding the underlying technology, the meaning of
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`terms to one skilled in the art, and how the invention works. Id. at 1317-19 (internal quotation
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`marks and citations omitted). Extrinsic evidence, however, is less reliable and less useful in
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`claim construction than the patent and its prosecution history. Id.
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`"A claim construction is persuasive, not because it follows a certain rule, but because it
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`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per
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`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would
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`exclude the inventor's device is rarely the correct interpretation." Osram GmbH v. Int'! Trade
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`Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks and citation omitted).
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 4 of 17 PageID #: 4858
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`III. AGREED-UPON CONSTRUCTIONS
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`1.
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`"poloxamers" ('652 patent: claims 7, 24)
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`a.
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`Agreed-upon construction: Compounds with the following structure:
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`2.
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`"a piston rod having a first external thread and a second external thread" (' 864
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`patent: claim 3)
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`a.
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`Agreed-upon construction: A piston rod with two different external
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`threads.
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`3.
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`"said piston rod comprises a first thread and a second thread" ('044 patent: claims
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`7, 17)
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`a.
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`Agreed-upon construction: A piston rod with two different threads.
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`4.
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`"where the first external thread is threadedly engaged with an insert" ('864 patent:
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`claim 3)
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`a.
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`Agreed-upon construction: The first external thread of the piston rod
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`interlocks with a threading of an insert.
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`IV.
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`CONSTRUCTION OF DISPUTED TERMS
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`A.
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`The Formulation Patents
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`1.
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`"at least one chemical entity chosen from" ('652 patent: claims 1, 7, 24;
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`'930 patent: claim 1)
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`a.
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`Plaintiffs' proposed construction: Plain and ordinary meaning.
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`b.
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`Defendant's proposed construction: At least one ingredient
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`selected for inclusion in the claimed formulation from the set of specified ingredients.
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`c.
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`Court's construction: No construction is necessary.
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`During oral argument, the parties agreed that no construction is necessary for this term.
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`(D.1. 178 at 32:6-33: 18). The Court has no trouble understanding this term, and thus adopts the
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`term's plain and ordinary meaning.
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`2.
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`"esters and ethers of polyhydric alcohols" ('930 patent: claim 1)
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`a.
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`Plaintiffs' proposed construction: Chemical compounds in which
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`one or more of the hydroxyl groups of a polyhydric alcohol has been replaced by or converted to
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`an ester (RCOO-X) or ether (RC-0-X) group.
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`b.
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`Defendant's proposed construction: Surfactant compounds with
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`0
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`the following structures: R-O-C-C-X (esters); and R-0-C-X (ethers) where R is an alcohol
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`with one or more OH groups, and X is unspecified.
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`c.
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`Court's construction: Chemical compounds in which one or more
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`of the hydroxyl groups of a polyhydric alcohol instead of being a hydroxyl group is an ester
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`(RCOO-X) or ether (RC-0-X) group. 3
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`Sanofi argues that Lilly's proposed construction "narrow[s] the scope of this claim term
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`by requiring that the ester or ether of a polyhydric alcohol also be an alcohol." (D.I. 13 7 at 27).
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`Lilly, on the other hand, objects to Sanofi's proposed construction because it defines the claimed
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`product by reference to a synthetic process, i.e., requiring that "one or more of the hydroxyl
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`groups of a polyhydric alcohol has been replaced by or converted to an ester (RCOO-X) or ether
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`3 Notwithstanding the different nomenclature in the proposed constructions, the parties claim to agree on the
`definitions of esters, ethers, alcohols, and hydroxyl groups. (D.I. 137 at 26 n. l 0 & 28).
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 6 of 17 PageID #: 4860
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`(RC-0-X) group." (Id. at 29). Lilly does not point to any meaningful intrinsic record support for
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`its position that an ester or ether of a polyhydric alcohol must also be an alcohol. Thus, the
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`Court finds that Sanofi's proposed construction more clearly conveys the term's meaning. The
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`Court, however, replaces the phrase "has been replaced by or converted to" with "instead of
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`being a hydroxyl group is" to account for Lilly's objection to Sanofi's construction.4
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`3.
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`"polysorbate" ('652 patent: claims 7, 24)
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`During oral argument, the Court scheduled a hearing for Friday, January 23, 2015 at 2:00
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`p.m., where each party will present an expert witness to testify about the construction of the
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`terms: "polysorbate"; "polysorbate 20"; and "polysorbate 80." (D.I. 178 at 167:22-170:8). The
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`parties must submit written declarations from their expert witnesses by the close of business on
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`Friday, January 16,2015. (Id. at 170:10-171:10).
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`a.
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`b.
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`Plaintiffs' proposed construction: Plain and ordinary meaning.
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`Defendant's proposed construction: Compounds with the
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`following structure:
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`or
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`where w+x+y+z is approximately 4, 5, or 20, and where R is a fatty acid.
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`c.
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`Court's construction: To be determined at a later date.
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`4 Sanofi does not oppose the substance of Lilly's objection. (D.1. 137 at 27 n.11 ).
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 7 of 17 PageID #: 4861
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`4.
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`"polysorbate 20" and "polysorbate 80" (' 652 patent: claims 1, 2, 8, 23)
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`a.
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`b.
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`Plaintiffs' proposed construction: Plain and ordinary meaning.
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`Defendant's proposed construction: Compounds with the
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`following structure:
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`where w+x+y+z is approximately 20, and R is fatty acids present in the following amounts:
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`b
`[ti
`or po ysor ate
`Carbon-
`Chain
`Len 2th
`6
`8
`10
`12
`14
`16
`18
`18
`18
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`20]
`Number of
`Double
`Bonds
`0
`0
`0
`0
`0
`0
`0
`1
`2
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`[ti
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`b t 80] or po ysor a e
`Fatty Acid
`Myristic acid
`Palmitic acid
`Palmitoleic acid
`Stearic acid
`Oleic acid
`Linoleic acid
`Linolenic acid
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`Percentage
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`s 1.0
`s 10.0
`s 10.0
`40.0-60.0
`14.0-25.00
`7.0-15.0
`s 7.0
`s 11.0
`s 3 .0
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`Percenta2e
`:::;5.0
`s 16.0
`s 8.0
`:::;6.0
`2': 58.0
`s 18.0
`:::;4.0
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`c.
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`Court's construction: To be determined at a later date.
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 8 of 17 PageID #: 4862
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`Lilly makes clear that "[t]he dispute between the parties is about the different fatty acid
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`chains that constitute the different polysorbates at issue." (DJ. 137 at 39). As noted above, the
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`Court will take further evidence on the polysorbate 20 and 80 terms.
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`5.
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`"the polysorbate 20 is present in an effective amount to avoid turbidity"
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`('652 patent: claim 8)
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`a.
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`Plaintiffs' proposed construction: The polysorbate 20 is present in
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`an effective amount to prevent visible cloudiness in daylight for at least 28 days.
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`b.
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`Defendant's proposed construction: The amount of polysorbate 20
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`(as defined above) present must prevent turbidity.
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`c.
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`Court's construction: No construction is necessary.
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`The Court does not find either parties' construction particularly helpful. Sanofi' s
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`proposed construction adds a limitation that is not supported by the intrinsic record-i. e., that
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`polysorbate 20 must prevent turbidity "for at least 28 days." (D.I. 137 at 42). Lilly's proposed
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`construction does not provide any additional clarity to the claim language. The parties agree that
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`polysorbate 20 must be present in an amount that prevents "turbidity," i.e., "visible cloudiness."
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`(Id.). Thus, the Court has no trouble understanding the words of this term, and gives the words
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`their plain and ordinary meaning. Therefore, no construction is necessary.
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`6.
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`"phenols" ('652 patent: claim 3; '930 patent: claim 2)
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`a.
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`Plaintiffs' proposed construction: Chemical compounds containing
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`a phenol group.
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`group.
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`b.
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`c.
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`Defendant's proposed construction: No construction is necessary.
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`Court's construction: Chemical compounds containing a phenol
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 9 of 17 PageID #: 4863
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`Lilly does not oppose Sanofi's proposed construction. (D.1. 137 at 44). Therefore, the
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`Court adopts Sanofi' s construction.
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`B.
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`The Device Patents
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`1.
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`"thread/threading" ('864 patent: claims 2, 3; '044 patent: claims 1, 7, 10,
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`11, 17, 20; '069 patent: claim 1)
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`a.
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`Plaintiffs' proposed construction: A rib or groove on a first
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`structure that engages a corresponding groove or rib on a second structure.
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`b.
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`Defendant's proposed construction: A helical rib or groove on a
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`first structure that engages a corresponding helical groove or rib on a second structure.
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`c.
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`Court's construction: A rib or groove on a first structure that
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`engages a corresponding groove or rib on a second structure.
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`The only point of dispute between the parties is whether the word "helical" should be
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`included before "groove" in the construction. (D.I. 137 at 45). The Court agrees with Sanofi
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`that Lilly's proposed construction places a limitation on the claim term that is not required by the
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`claim language. Claim differentiation requires that "claims are interpreted with an eye toward
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`giving effect to all terms in the claim." Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed.
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`Cir. 2006). For example, the Federal Circuit has held that the use of the term "steel baffles" in a
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`claim "strongly implies that the term 'baffles' does not inherently mean objects made of steel."
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`Phillips v. AWHCorp., 415 F.3d 1303, 1314 (Fed. Cir. 2005). In the '864 patent, claims 1and2
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`refer to the "housing" and the "dose dial sleeve" as having a "helical thread" (D.1. 95, Ex.Cat
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`47, 17:4-18), while claim 3 refers to the "piston rod" as having a "first external thread" and a
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`"second external thread," with no description of those threads as being "helical." (Id at 47,
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`17:35-39). When some components are referred to as having "helical threads," and others are
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 10 of 17 PageID #: 4864
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`referred to as simply having "threads," it is logical to interpret "thread" as being broader in scope
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`than "helical thread." Lilly makes no argument that the invention requires a helical thread to
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`work where it does not expressly state that the thread is helical. Therefore, the Court will not
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`import the word "helical" into its construction of the term "thread/threading."
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`2.
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`"drive sleeve" ('864 patent: claims 2, 3; '044 patent: claims 1, 3, 11, 13;
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`'069 patent: claim 1)
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`a.
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`b.
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`Plaintiffs' proposed construction: Plain and ordinary meaning.
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`Defendant's proposed construction: A continuous cylindrical or
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`tubular component of circular cross-section that encloses another part.
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`c.
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`Court's proposed construction: An essentially tubular component
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`of essentially circular cross-section which is further releasably connected to the dose dial sleeve.
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`The parties submitted supplemental letter briefs on Friday, January 9, 2015, providing
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`additional analysis as to whether the Court should import the lexicographical definition of "drive
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`sleeve" from the '864 patent into the '044 and '069 patents. (D.1. 183 & 184). The '864 patent
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`defines "drive sleeve" as "any essentially tubular component of essentially circular cross-section
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`and which is further releasably connected to the dose dial sleeve." (D.I. 95, Ex.Cat 40, 3:61-
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`64). The Federal Circuit has made clear that courts are to "presume, unless otherwise compelled,
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`that the same claim term in the same patent or related patents carries the same construed
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`meaning." Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1334 (Fed. Cir. 2003). The
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`parties agree that the three device patents claim priority to a common foreign patent
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`application-GB 0304822.0. (D.1. 183 at 2).
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`Sanofi argues that only part of the lexicographical definition of "drive sleeve" should be
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`adopted because the limitation requiring the drive sleeve to be "releasably connected to the dose
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`dial sleeve" is not included in the '044 and '069 claims. (D .I. 183 at I). Sanofi contends that
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`this limitation only appears once in the '044 and '069 specifications, in a preferred embodiment,
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`and should not be imported into the claims. (D.I. 95, Ex. D at 11, I :62-66). Lilly, on the other
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`hand, argues that all three patents claim priority to the same patent application, and thus the same
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`claim terms in each patent should be given the same construction. (D.I. 184 at 2). Lilly further
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`maintains that Sanofi cannot pick and choose which parts of the lexicographical definition to
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`keep and which parts to discard. (Id.). The Court agrees with Lilly that the term "drive sleeve"
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`is used in the same manner throughout the three device patents. Further, Sanofi has not
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`presented a compelling reason to disregard the Federal Circuit's presumption in favor of
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`construing the same terms in related patents the same. Therefore, the Court adopts the
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`construction provided by the patentee in the '864 patent.
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`3.
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`"a drive sleeve releasably connected to the dose dial sleeve" ('864 patent:
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`claim 2)
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`a.
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`Plaintiffs' proposed construction: Configured to be coupled and
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`decoupled at least with respect to axial or rotational movement.
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`b.
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`Defendant's proposed construction: A drive sleeve that is
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`connected to the dose dial sleeve during one phase of operation and disconnected from the dose
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`dial sleeve during another phase of operation.
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`c.
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`Court's construction: A drive sleeve that is reversibly joined to the
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`dose dial sleeve, which allows coupling and decoupling.
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`The '864 patent defines "releasably connected" as "two components of instant
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`mechanism or device are reversibly joined to each other, which allows coupling and decoupling,
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`e.g. by means of a clutch." (D.I. 95, Ex.Cat 40, 4:7-11). This is a lexicographical definition.
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`Case 1:14-cv-00113-RGA-MPT Document 192 Filed 01/20/15 Page 12 of 17 PageID #: 4866
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`Thus, the Court adopts this construction in the context of the drive sleeve and the dose dial
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`sleeve.
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`4.
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`"clutch mechanism" ('864 patent: claim 2) and "tubular clutch" ('044
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`patent: claims 1, 2, 6, 8, 11, 12, 16, 18; '069 patent: claims 1, 3)
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`a.
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`Plaintiffs' proposed construction: A first component that couples
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`and decouples at least a second component to a third component.
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`b.
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`Defendant's proposed construction: A structure that couples and
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`decouples a moving component from another component.
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`c.
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`Court's construction: A structure that couples and decouples a
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`moveable component from another component.
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`The '864 patent defines "clutch means" as:
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`[A ]ny means, which releasably connects the dose dial sleeve and the
`drive sleeve and which is designed to allow rotation of the dose dial
`sleeve and the drive sleeve with respect to the housing when the dose
`dial sleeve and the drive sleeve are coupled and, when both are de(cid:173)
`coupled, allows rotation of the dose dial sleeve with respect to the
`housing, but does not allow rotation of the drive sleeve with respect
`to the housing and allows axial movement of the drive sleeve.
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`(D.I. 95, Ex.Cat 40, 4:56-64). During oral argument, Sanofi agreed to the inclusion of "a
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`moveable component" in the construction of"clutch mechanism." (D.I. 178 at 127:13-129:10).
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`The parties further agree that "clutch" as used in "clutch mechanism" and "tubular clutch"
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`should be construed the same, and that a "clutch" couples and decouples two different
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`components. (D.1. 137 at 67). The only point of contention is "whether the claims require that
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`the 'clutch' be a separate component of the claimed devices ... or merely a 'structure' that could
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`reside on another, separately claimed component." (Id.). Sanofi argues that "use of the term
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`'clutch' in the claims requires that it be an independent 'first component that couples and
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`decouples at least a second component to a third component.'" (Id.). The Court disagrees with
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`Sanofi, and finds that "structure" is a suitable word to describe the term "clutch mechanism."
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`Therefore, the Court adopts Lilly's proposed construction, but replaces "a moving component"
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`with "a moveable component."
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`5.
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`"tubular clutch" ('044 patent: claims 1-2, 6, 8, 11-12, 16, 18; '069 patent:
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`claims 1, 3)
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`a.
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`b.
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`Plaintiffs' proposed construction: Plain and ordinary meaning.
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`Defendant's proposed construction: A clutch in the shape of a
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`continuous hollow cylinder of circular cross-section.
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`c.
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`Court's construction: A clutch having the shape of a hollow
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`cylindrical structure.
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`During oral argument, the parties agreed that the word "tubular" means both "hollow"
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`and "cylindrical." (D.I. 178 at 114:12-18). The parties also agreed that a "tubular clutch" does
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`not need to be "continuous" or have "circumferential ends." (Id. at 123:18-21 & 126:17-22). In
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`light of this, the Court finds that a "tube" is "a hollow cylindrical structure," and that "tubular"
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`means "having the shape of a tube." Lilly argues that the construction should include "of
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`circular cross-section," but nothing in the intrinsic record requires that the cross-section be
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`"circular." The cross-section could, for example, be oval. Therefore, the Court construes the
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`term "tubular clutch" as "a clutch having the shape of a hollow cylindrical structure."
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`6.
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`"a clutch mechanism located between the dose dial sleeve and the drive
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`sleeve" ('864 patent: claim 2)
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`a.
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`Plaintiffs' proposed construction: A clutch mechanism spatially
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`positioned to engage with the dose dial sleeve and the drive sleeve.
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`b.
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`Defendant's proposed construction: A clutch mechanism
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`positioned in the cylindrical space that separates the dose dial sleeve and the drive sleeve.
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`c.
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`Court's construction: No construction is necessary.
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`The Court agrees with Sanofi that Lilly's "in the cylindrical space" limitation is not
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`supported by the intrinsic record, and agrees with Lilly that Sanofi' s "spatially positioned"
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`language is vague and unhelpful to construction. (D.I. 137 at 79-80). The Court finds that
`
`"located between" is made of ordinary English words, which the Court has no trouble
`
`understanding. Therefore, the Court adopts the term's plain and ordinary meaning.
`
`7.
`
`"the clutch mechanism is configured such that ... when the dose dial
`
`sleeve and the drive sleeve are decoupled ... rotation of the drive sleeve with respect to the
`
`housing is prevented" ('864 patent: claim 2)
`
`a.
`
`b.
`
`Plaintiffs' proposed construction: Plain and ordinary meaning.
`
`Defendant's proposed construction: A clutch mechanism design
`
`that stops the drive sleeve from rotating with respect to the housing when the dose dial sleeve
`
`and drive sleeve are decoupled.
`
`c.
`
`Court's construction: No construction is necessary.
`
`Sanofi argues that Lilly's proposed construction "rearranges the plain language of the
`
`claim, adds a new term ('clutch mechanism design') not found in either the claim or the
`
`specification, and assigns an active role to that new term by requiring it to actively prevent
`
`rotation of the drive sleeve with respect to the housing ('a clutch mechanism design that stops')."
`
`(D.I. 137 at 84). Further, Sanofi argues that the claim language "does not require that any
`
`particular element actively prevent the rotation," but rather "only requires that when the dose dial
`
`sleeve and the drive sleeve are decoupled, rotation of the drive sleeve 'is prevented."' (Id).
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`Lilly relies upon the specification, which states that when the dose dial sleeve and drive sleeve
`
`are decoupled the "clutch means" "does not allow rotation of the drive sleeve with respect to the
`
`housing and allows axial movement of the drive sleeve." (D.I. 95, Ex.Cat 40, 4:61-64). The
`
`Court agrees with Sanofi that Lilly's proposed construction places an unsupported limitation on
`
`the claim language by requiring "a clutch mechanism design that stops the drive sleeve from
`
`rotating." The Court finds that the term is made of ordinary English words and words that have
`
`already been construed in this opinion. Therefore, the Court has no trouble understanding the
`
`meaning of the term, and adopts the term's plain and ordinary meaning.
`
`8.
`
`"dose dial grip" ('044 patent: claims 1-2, 4-5, 11-12, 14-15; '069 patent:
`
`claims 1-3)
`
`to dial a dose.
`
`a.
`
`Plaintiffs' proposed construction: A component that a user rotates
`
`b.
`
`Defendant's proposed construction: A component secured to the
`
`dose dial sleeve that a user rotates to dial a dose.
`
`c.
`
`Court's construction: A component that a user rotates to dial a
`
`dose.
`
`The only point of dispute is whether the "dose dial grip" must be "secured to the dose
`
`dial sleeve." (D.I. 137 at 86). Lilly argues that the '044 specification discloses that "[t]he dose
`
`dial grip 76 is secured to the dose dial sleeve 70 to prevent relative movement therebetween."
`
`(D.I. 95, Ex. D at 13, 5:26-28). Further, Lilly argues that the claim language is "expressly tied
`
`to its usage in the specification" because the applicants for both the '044 and '864 patents
`
`amended the claim language from "dose knob" to "dose dial grip" after the PTO rejected the
`
`"dose knob" term for lack of written description. (Id., Exs. Pat p.9 & Nat p.4). Sanofi argues
`
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`that the claims do not require that the dose dial grip be "secured to" the dose dial sleeve, and that
`
`Lilly seeks to limit "dose dial grip" to a preferred embodiment. (D.I. 137 at 87). The Court
`
`agrees with Sanofi and finds that the '044 specification describes the "dose dial grip" as "secured
`
`to the dose dial sleeve" in a preferred embodiment, which does not, by itself, limit the claim
`
`language. Therefore, the Court adopts Sanofi' s construction.
`
`9.
`
`"said piston rod is non-rotatable during a dose setting step relative to said
`
`main housing" ('044 patent: claims 1, 11; '069 patent: claim 1)
`
`a.
`
`b.
`
`Plaintiffs' proposed construction: Plain and ordinary meaning.
`
`Defendant's proposed construction: A rotatable piston rod that is
`
`prevented from rotating at the time when the dose is being set.
`
`c.
`
`Court's construction: A piston rod that is prevented from rotating
`
`at the time when the dose is being set.
`
`The parties only disagree on whether the construction should include a "rotatable piston
`
`rod." (D.I. 137 at 91). The '864 specification defines "piston rod" as "a component adapted to
`
`operate through/within the housing, designed to translate axial movement through/within the
`
`drug delivery device, preferably from the drive sleeve to the piston, for the purpose of
`
`discharging/dispensing an injectable product." (D.I. 95, Ex.Cat 40, 4:14-18). The patentee's
`
`definition does not require the piston rod to be "rotatable." Lilly's proposed construction adds a
`
`limitation to the claim that is not reflected in the claim language or the specification. Therefore,
`
`the Court adopts Lilly's construction without "rotatable."
`
`10.
`
`"said housing" (' 044 patent: claims 1, 11; '069 patent: claim 1)
`
`a.
`
`Plaintiffs' proposed construction: The main housing.
`
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`b.
`
`Defendant's proposed construction: Not capable of construction;
`
`no antecedent basis.
`
`c.
`
`Court's construction: The main housing.
`
`Lilly argues that claims 1 and 11 of the '044 patent identify two housing components, and
`
`that "said housing" refers to "[a] housing part" rather than "a main housing." (DJ. 95, Ex. D at
`
`13, 6:57-60 & 14, 8:7-10). Sanofi, on the other hand, argues that "[t]here is only one housing in
`
`the body of the claims: the main housing," and thus all references to "housing" in the body of
`
`claims 1 and 11 are to the "main housing." (D.I. 137 at 96). The Court agrees with Sanofi that
`
`the preambles to claims 1 and 11 do not limit the scope of the claims, and that all references in
`
`the body of the claims refer to the "main housing" and not the "housing part." Therefore, the
`
`Court adopts Sanofi' s construction. The Court does so while acknowledging that the use of "said
`
`housing" and "said main housing" in the same limitation (e.g., '044 patent, 6:61-63) makes the
`
`issue less than crystal clear. The Court is convinced, however, that, in context, it is clear that
`
`"said housing" is referring to the main housing.
`
`11.
`
`"plunger" ('069 patent: claim 2)
`
`a.
`
`b.
`
`c.
`
`Plaintiffs' proposed construction: Cartridge piston.
`
`Defendant's proposed construction: No construction is necessary.
`
`Court's construction: Cartridge piston.
`
`Lilly does not object to Sanofi's proposed construction. (D.1. 137 at 97). Therefore, the
`
`Court adopts Sanofi' s construction.
`
`V.
`
`CONCLUSION
`
`Within five days the parties shall submit a proposed order consistent with this
`
`Memorandum Opinion.
`
`17